CLINICAL TRIALS PROFILE FOR CHOLESTYRAMINE LIGHT

All Clinical Trials for CHOLESTYRAMINE LIGHT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000461 ↗	Harvard Atherosclerosis Reversibility Project (HARP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1986-12-01	To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00000463 ↗	Post Coronary Artery Bypass Graft (CABG) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-04-01	To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000488 ↗	Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1973-06-01	To determine whether reduction of cholesterol by drug therapy significantly lowered the atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise healthy men. Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a year-by-year breakdown.
NCT00000594 ↗	NHLBI Type II Coronary Intervention Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1971-11-01	To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	Hennepin County Medical Center, Minneapolis	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.

Clinical Trial Conditions for CHOLESTYRAMINE LIGHT

Condition Name

Condition Name for CHOLESTYRAMINE LIGHT
Intervention	Trials
Cardiovascular Diseases	4
Myocardial Ischemia	4
Coronary Disease	4
Heart Diseases	4

Condition MeSH

Condition MeSH for CHOLESTYRAMINE LIGHT
Intervention	Trials
Hypercholesterolemia	5
Ischemia	4
Heart Diseases	4
Coronary Disease	4

Clinical Trial Locations for CHOLESTYRAMINE LIGHT

Trials by Country

Trials by Country for CHOLESTYRAMINE LIGHT
Location	Trials
United States	45
Germany	9
Netherlands	5
Canada	5
France	4

Trials by US State

Trials by US State for CHOLESTYRAMINE LIGHT
Location	Trials
California	4
North Carolina	4
Missouri	4
Ohio	3
Texas	2

Clinical Trial Progress for CHOLESTYRAMINE LIGHT

Clinical Trial Phase

Clinical Trial Phase for CHOLESTYRAMINE LIGHT
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for CHOLESTYRAMINE LIGHT
Clinical Trial Phase	Trials
Completed	29
Recruiting	7
Active, not recruiting	2

Clinical Trial Sponsors for CHOLESTYRAMINE LIGHT

Sponsor Name

Sponsor Name for CHOLESTYRAMINE LIGHT
Sponsor	Trials
Sanofi	7
National Heart, Lung, and Blood Institute (NHLBI)	4
Regeneron Pharmaceuticals	3

Sponsor Type

Sponsor Type for CHOLESTYRAMINE LIGHT
Sponsor	Trials
Other	41
Industry	21
NIH	9

Last updated: July 28, 2026

Cholestyramine Light clinical trials update, market analysis, and market projection

Cholestyramine Light is an established bile-acid sequestrant for hypercholesterolemia and adjunctive therapy for bile-acid diarrhea and related cholestatic syndromes. Public clinical development activity is limited, with the product class largely in “legacy” territory rather than active late-stage pipelines. Market outlook is driven by generic erosion, guideline position, tolerability and adherence tradeoffs (notably constipation and drug-drug interactions), and substitution effects from newer lipid-lowering therapies.

No sufficient dataset is available in the provided context to produce a complete, cite-backed clinical trials update, market sizing basis, and forward projection that withstands due-diligence scrutiny.

What clinical trials exist for cholestyramine light (bile acid sequestrant) and who is running them?

Featured-snippet answer: There is no reliable, comprehensive trial registry snapshot available here to enumerate active or recently completed interventional studies for “Cholestyramine Light” specifically (as distinct from the cholestyramine class).

Which trial registry entries matter (NCT, EudraCT)

A robust update requires:

• A query map for “Cholestyramine Light” and for cholestyramine formulations that match the brand label and strengths.
• Filtering by interventional status, recruitment status, indication, and route.
• Linking to sponsors and results postings.

No such trial list is available in the supplied material.

What endpoints are typically used in bile-acid sequestrant trials

Common endpoints include:

• LDL-C reduction and lipid panel changes
• Bile acid and stool metrics for diarrheal indications
• Safety endpoints dominated by GI tolerability (constipation) and adherence

How big is the cholestyramine light market and what segment is it in (lipids vs bile-acid diarrhea)?

Featured-snippet answer: No source-backed market segment split or sales dataset is available in the provided context.

Drivers

• Primary hypercholesterolemia use has shifted toward statins and combination therapy.
• Bile-acid diarrhea indications can retain use where other therapies are less available or when bile-acid sequestration is preferred.

Constraints

• Drug-drug interaction burden via sequestration in the GI tract.
• GI adverse events, which affect adherence and persistence.

When do cholestyramine light patents expire and what is the Orange Book status?

Featured-snippet answer: Cholestyramine is widely available as generics; a brand-specific Orange Book status requires product-level Orange Book record data that is not present here.

Patent estate structure (typical for legacy small molecules)

• Composition, formulation, and process patents often expired years ago.
• Remaining IP, if any, is usually weak and not tied to meaningful exclusivity.

Which generics compete with cholestyramine light and what are the substitution risks?

Featured-snippet answer: The key competitive risk is generic substitution across cholestyramine formulations, since cholestyramine is off-patent in most jurisdictions.

Formulation substitution

• Powder sachets and similar bile-acid sequestrant presentations compete primarily on dose convenience and tolerability.

How does cholestyramine light compare with alternative lipid-lowering agents (statins, ezetimibe, PCSK9, bempedoic acid)?

Featured-snippet answer: Cholestyramine’s competitive role is mostly as an adjunct where statin-based regimens are insufficient or when bile-acid sequestration is clinically targeted.

Adherence and tolerability tradeoffs

• Newer agents have fewer GI interaction burdens.
• Cholestyramine’s GI side effects and interaction profile commonly limit long-term persistence.

What market projection scenarios apply to cholestyramine light from 2026 to 2035?

Featured-snippet answer: A defensible projection requires baseline sales and time-series data. No baseline is available in the provided context, so projections cannot be produced in a due-diligence-ready format.

Scenario drivers to model

• Continued generic price compression
• Formulary position in lipid pathways
• Uptake in bile-acid diarrhea and related indications
• Competitive pressure from bile-acid targeted agents and non-sequestrant lipid options

What regulatory pathway issues affect cholestyramine light (FDA labeling, REMS, exclusivity)?

Featured-snippet answer: Cholestyramine products are not typically managed under REMS-style frameworks; labeling and generic approvals govern ongoing access, but product-level regulatory and exclusivity data are not provided here.

What patent litigation affects cholestyramine light and biosimilar risk?

Featured-snippet answer: No litigation dataset is available in the provided context; biosimilar risk is not applicable because cholestyramine is a small-molecule.

Key Takeaways

• Cholestyramine Light is an established bile-acid sequestrant with limited evidence of brand-specific late-stage clinical development in the provided context.
• Market activity is likely dominated by generic availability and guideline-driven substitution toward other lipid-lowering therapies.
• A credible clinical-trials update and quantified market projection cannot be produced from the information provided here.

FAQs

1. What are the most common adverse events reported for cholestyramine-based bile-acid sequestrants?
2. How do cholestyramine drug-drug interactions change dosing strategies for chronic therapy?
3. What indications other than hypercholesterolemia are most relevant for cholestyramine use?
4. How do bile-acid sequestrants compare to ezetimibe as add-on therapy to statins?
5. What factors drive formulary adoption or exclusion of generic cholestyramine products?

References

No sources were provided in the prompt, so no numbered reference list can be generated.